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Trial registered on ANZCTR


Registration number
ACTRN12616001400459
Ethics application status
Approved
Date submitted
5/10/2016
Date registered
10/10/2016
Date last updated
10/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The potential benefits of high and low carotenoid-rich fruits and vegetables on preserving skeletal muscle mass in overweight/obese older adults when placed on a weight loss diet.
Scientific title
The potential benefits of high and low carotenoid-rich fruits and vegetables on preserving skeletal muscle mass in overweight/obese older adults during energy restriction.
Secondary ID [1] 290269 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 300499 0
Ageing 300500 0
Body Composition Assessment 300501 0
Sarcopenia and Frailty 300502 0
Condition category
Condition code
Diet and Nutrition 300358 300358 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is intended to be a 12-week randomized control trial in older adults >60 years. After a 1-week run-in period, participants will be randomly allocated to receive either:

1. A 12 week prescribed and individualized energy restricted diet to promote weight loss involving high carotenoid fruits and vegetables and extra-virgin olive oil; OR
2. A 12 week prescribed and individualized energy restricted diet to promote weight loss and low carotenoid fruits and vegetables, without extra-virgin olive oil

During the one week run-in period (occurring after baseline) participants will be instructed to consume 100% of their habitual dietary intake before commencing the diet.

The intervention diets are isocaloric (matched for energy and macronutrient distribution) with energy intake restricted by 30% of estimated requirements using the Mifflin equation. Diets are presented in the form of a checklist and are designed using energy bands ranging from 5000-8000KJ. Depending on the energy restriction, participants will be required to consume 225-375g high or low carotenoid vegetables per day. Specific examples of high carotenoid vegetables include, orange, red or yellow fruits and vegetables in addition to dark green leafy vegetables.

Despite the two diets being matched for energy and macronutrient distribution, the composition of dietary fat will differ. Participants randomized to receive high carotenoid fruits and vegetables will also be prescribed olive oil. Prescription of the oil will depend on the energy restriction, however this will range from 40-70ml per day. Participants randomized to receive low carotenoid fruits and vegetables will be prescribed an alternative oil (Rice Bran or Canola oil).

Irrespective of which group participants are allocated, all participants will receive a fortnightly fruit and vegetable hamper that reflects the types of fruits and vegetables they are required to consume. Participants randomized to the high-carotenoid fruits and vegetables, plus extra-virgin olive oil group will receive the olive oil throughout the duration of the study. All other food(s) allocated in the diet is o be provided by the participant.

Throughout the 12-week intervention, participants will receive fortnightly (individual) dietary counselling sessions by an Accredited Practising Dietitian (APD). Each of these sessions will run for approximately 30 minutes in duration and will be used to assess compliance of the dietary protocol. During each session, the dietary protocol will be adjusted (scaled up or down) whenever required, depending on the rate of weight loss and/or weight maintenance.
Intervention code [1] 296068 0
Prevention
Intervention code [2] 296085 0
Treatment: Other
Comparator / control treatment
The control group will receive:

A 12 week prescribed and individualized energy restricted diet to promote weight loss and low carotenoid fruits and vegetables, without extra-virgin olive oil
Control group
Active

Outcomes
Primary outcome [1] 299815 0
Body Composition (skeletal muscle mass; fat-free mass; fat-mass) assessed using Dual-Energy X-Ray Absorptiometry (DEXA)
Timepoint [1] 299815 0
Baseline and 12-weeks
Primary outcome [2] 299816 0
Muscle Strength assessed as grip-strength using a hand-held dynamometer
Timepoint [2] 299816 0
Baseline and 12-weeks
Primary outcome [3] 299817 0
Physical performance assessed using the Physical Performance Battery (balance, timed sit-to-stand and usual gait speed)
Timepoint [3] 299817 0
Baseline and 12-weeks
Secondary outcome [1] 328195 0
Quality of Life assessed using the 36-item Short Form health instrument (SF-36)
Timepoint [1] 328195 0
Baseline and 12-weeks
Secondary outcome [2] 328229 0
Physical activity status assessed using the International Physical Activity Questionnaire (IPAQ)
Timepoint [2] 328229 0
Baseline and 12 weeks
Secondary outcome [3] 328230 0
Adherance to a Mediterranean dietary pattern assessed using the 14-item Mediterranean Diet Questionnaire
Timepoint [3] 328230 0
Baseline only

Eligibility
Key inclusion criteria
Community-dwelling older adults over the age of 60 years
Overweight or obese (BMI greater than 27kg.m2)
Otherwise healthy
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI less than 27kg.m2
Reside in high level residential care
Dementia or cognitive impairment
Type 2 diabetes (medicated with insulin)
Cancer
Renal or liver disease
Unstable CVD
Neurological disease
Current use of anti-inflammatory or corticosteroid medications
Current involvement in a secondary study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Previous literature has reported that exercise significantly attenuates the loss of FMM in older obese adults when placed on an energy-restricted diet (exercise + weight loss: 1.8 +/- 1.5; weight loss only: 3.5 +/- 2.1 kg; P = 0.02). Therefore, a sample size of n = 24 per group is expected to achieve this difference at 12 weeks at 80% statistical power and a significance level set at a=0.05. Assuming an attrition rate of ~20%, a total of n = 60 participants will be recruited (n = 30 per group).

All statistical analysis will be performed using SPSS. Unless otherwise stated, all descriptive statistics will be expressed as means and standard deviations. One-way analysis of variance (ANOVA) will be used to determine significant differences for all mean outcome measures between the two groups. Independent samples t-test will be used to determine differences for all outcome measures between the two groups at week 12. Dietary adherence will be assessed using dietary intake checklists with adherence presented as a percentage.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/08/2016
Date of last participant enrolment
Anticipated
31/03/2017
Actual
Date of last data collection
Anticipated
30/06/2017
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 14423 0
4558 - Maroochydore
Recruitment postcode(s) [2] 14424 0
4575 - Birtinya
Recruitment postcode(s) [3] 14425 0
4551 - Caloundra
Recruitment postcode(s) [4] 14426 0
4556 - Buderim
Recruitment postcode(s) [5] 14427 0
4556 - Sippy Downs
Recruitment postcode(s) [6] 14428 0
4575 - Wurtulla

Funding & Sponsors
Funding source category [1] 294641 0
University
Name [1] 294641 0
University of the Sunshine Coast
Country [1] 294641 0
Australia
Funding source category [2] 294654 0
Commercial sector/Industry
Name [2] 294654 0
Good Harvest
Country [2] 294654 0
Australia
Funding source category [3] 294655 0
Commercial sector/Industry
Name [3] 294655 0
Cobram Estate
Country [3] 294655 0
Australia
Primary sponsor type
Individual
Name
Dr Anthony Villani
Address
School of Health and Sport Sciences
Faculty of Science, Health, Education and Engineering
90 Sippy Downs Dr, Sippy Downs QLD 4556
Country
Australia
Secondary sponsor category [1] 293505 0
University
Name [1] 293505 0
University of the Sunshine Coast
Address [1] 293505 0
School of Health and Sport Sciences
Faculty of Science, Health, Education and Engineering
90 Sippy Downs Dr, Sippy Downs QLD 4556
Country [1] 293505 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296077 0
Human Research Ethics Comittee; University of the Sunshine Coast
Ethics committee address [1] 296077 0
Ethics committee country [1] 296077 0
Australia
Date submitted for ethics approval [1] 296077 0
12/04/2016
Approval date [1] 296077 0
24/05/2016
Ethics approval number [1] 296077 0
(A/16/801)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69466 0
Dr Anthony Villani
Address 69466 0
School of Health and Sport Sciences
Faculty of Science, Health, Education and Engineering
University of the Sunshine Coast
90 Sippy Downs Dr, Sippy Downs QLD 4556
Country 69466 0
Australia
Phone 69466 0
+61 7 5456 3546
Fax 69466 0
Email 69466 0
avillani@usc.edu.au
Contact person for public queries
Name 69467 0
Anthony Villani
Address 69467 0
School of Health and Sport Sciences
Faculty of Science, Health, Education and Engineering
University of the Sunshine Coast
90 Sippy Downs Dr, Sippy Downs QLD 4556
Country 69467 0
Australia
Phone 69467 0
+61 7 5456 3546
Fax 69467 0
Email 69467 0
avillani@usc.edu.au
Contact person for scientific queries
Name 69468 0
Anthony Villani
Address 69468 0
School of Health and Sport Sciences
Faculty of Science, Health, Education and Engineering
University of the Sunshine Coast
90 Sippy Downs Dr, Sippy Downs QLD 4556
Country 69468 0
Australia
Phone 69468 0
+61 7 5456 3546
Fax 69468 0
Email 69468 0
avillani@usc.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled intervention study investigating the efficacy of carotenoid-rich fruits and vegetables and extra-virgin olive oil on attenuating sarcopenic symptomology in overweight and obese older adults during energy intake restriction: protocol paper.2018https://dx.doi.org/10.1186/s12877-017-0700-4
N.B. These documents automatically identified may not have been verified by the study sponsor.